MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA ULTIRRA SINUS BALLOON CATHETER WITH THE RELIEVA SIDEKICK ; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number BC0716RU

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2019

Event Type  malfunction  

Event Description

Physician inserted a 7mmx16mm relieva ultirra sinus balloon catheter into the left frontal sinus.Nurse inflated the balloon per physician order, on the first inflation the balloon ruptured.The same procedure using the same device was completed on the right frontal sinus.Nurse inflated the balloon and the balloon ruptured.Physician and attending nurse have performed numerous procedure using the same device.Fda safety report id# (b)(4).

• Brand Name: RELIEVA ULTIRRA SINUS BALLOON CATHETER WITH THE RELIEVA SIDEKICK
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC. ; irvine CA 9261 8
• MDR Report Key: 8970949
• MDR Text Key: 158638394
• Report Number: MW5089617
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BC0716RU
• Device Lot Number: 181029B-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 99